A군 사슬알균 인두염 진단을 위한 STANDARD F Strep A Ag FIA의 성능 평가
Performance Evaluation of STANDARD F Strep A Ag FIA for Diagnosis of Group A Streptococcal Pharyngitis
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배경: 인두염은 의료기관에서 흔히 접하는 질환이지만 A군 사슬알균 인두염과 바이러스성 인두염의 감별이 어렵다. STANDARD F Strep A Ag FIA (SD BIOSENSOR, Korea)는 최근에 개발된 A군 사슬알균 인두염 신속항원검사 키트로서, 본 연구에서는 STANDARD F Strep A Ag FIA의 성능을 평가하였다. 방법: 2018년 7월부터 2019년 10월까지 창원지역 5개 소아과의원을 방문한 372명의 소아를 대상으로 3개의 인두도말 검체를 채취하여, STANDARD F Strep A Ag FIA 검사와 Sofia Strep A FIA 검사를각 의료기관에서 시행하고, 나머지 한 검체는 창원경상대학교병원에서 배양검사를 시행하였다. STANDARD F Strep A Ag FIA와 Sofia Strep A FIA 신속항원검사 결과와 배양검사 결과를 비교하였다. 결과: 총 372명 중 109명(29.3%)이 STANDARD F Strep A Ag FIA 검사에서 양성이었고, 이 결과를 인두배양검사 결과와 비교하면 민감도, 특이도, 양성예측도, 음성예측도는 각각 95.0%, 95.2%, 88.1%, 98.1%였다. STANDARD F Strep A Ag FIA와 Sofia Strep A FIA의 검사 일치도는 96.5%, kappa 값은 0.89 로 높았다. 결론: STANDARD F Strep A Ag FIA 검사는 A군 사슬알균 인두염 진단 성능이 우수하였고, Sofia Strep A FIA와 높은 일치도를 보였다.
Abstract
Background: Pharyngitis is one of the most common conditions encountered in primary health care facilities. Accurate differentiation of group A streptococcus (GAS) infection from viral infection is difficult. The STANDARD F Strep A Ag FIA (SD BIOSENSOR, Korea) is a rapid antigen detection test (RADT) that has been recently developed for diagnosing GAS pharyngitis. In this study, we evaluated the diagnostic performance of the STANDARD F Strep A Ag FIA and compared the results between the RADT and conventional throat culture. Methods: Throat swab samples were obtained from a total of 372 children presenting pharyngitis symptoms in five pediatric clinics in Changwon, Korea from July 2018 to October 2019. A comparative study between STANDARD F Strep A Ag FIA and Sofia Strep A FIA (Quidel, USA) was performed. Two throat swabs were taken simultaneously from each patient for RADT. The third throat swab was stored in a transport tube containing Stuart's transport medium for culture. Performance and kappa index of STANDARD F Strep A Ag FIA were evaluated. Results: GAS infection was detected in 29.3% (109/372) patients, using the STANDARD F Strep A Ag FIA. The sensitivity, specificity, positive predictive value, and negative predictive value were 95.0%, 95.2%, 88.1%, and 98.1%, respectively. The STANDARD F Strep A Ag FIA showed an excellent concordance rate of 96.5% and a kappa value of 0.89 compared to Sofia Strep A FIA. Conclusion: The STANDARD F Strep A Ag FIA demonstrated an excellent performance along with Sofia Strep A FIA for the diagnosis of GAS pharyngitis.
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